Clinical Project Manager II – Biomarker Study M...

Description Clinical Project Manager II – Biomarker Study Management (Sponsor-Dedicated | Remote) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Clinical Project Manager II – Biomarker Study Management (Sponsor-Dedicated | Remote) We’re hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish. You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards. What You’ll Do: Lead Biomarker Study Operations • Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs • Serve as the operational point of contact for all biomarker-related processes • Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans • Plan and manage the collection, tracking, and analysis of biological specimens • Advise study teams on best practices for sample management and logistics Drive Clinical Project Delivery • Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout • Ensure studies stay on track with respect to timelines, budget, scope, and quality • Act as the main liaison between the sponsor and study partners • Monitor and manage project financials, ensuring fiscal responsibility • Proactively identify and resolve operational issues and risks Ensure Operational Excellence • Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness • Keep study systems and databases current and audit-ready • Prepare project reports and updates for sponsors and internal stakeholders • Plan and facilitate internal and external meetings • Support inspection readiness and regulatory compliance throughout the project Skills and Experience You Bring: • Significant experience managing biomarker studies and external vendors required! • Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting • Proven ability to coordinate complex sample collection and analysis workflows • Expertise in supporting study teams with sample logistics and operational planning • Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience • Experience in a clinical research organization (CRO) or sponsor environment preferred • Familiarity with GCP, ICH guidelines, and global regulatory standards • Strong project management, organizational, and communication skills • Comfortable working independently and embracing new technologies • Willingness to travel up to 25% as needed Why Join Us: • Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine. • Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients’ lives around the world. • Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters. • Flexibility: Enjoy the freedom of a fully remote role with the supp